FDA Approves New Sunscreen Ingredient Expanding Consumer Options

The U.S. Food and Drug Administration (FDA) has approved a new sunscreen ingredient for use in over-the-counter products sold in the United States. The agency issued the final administrative order for bemotrizinol on June 9, 2026. This marks the first addition to the sunscreen monograph in more than two decades. Regulators in Europe, Asia, and Canada authorized this UV filter years earlier, so the U.S. decision closes a gap that has existed for some time.

This development matters for sunscreen manufacturers, ingredient suppliers, and companies marketing sun care products in North America. The approval expands the toolkit of UV-blocking ingredients available to formulators. It may also reshape competitive dynamics in a market that has lagged behind international counterparts in ingredient diversity.

Understanding the FDA’s Approval Process  

Bemotrizinol is a broad-spectrum UV filter that absorbs both UVA and UVB radiation. It has been widely used in sunscreen products across Europe, Australia, and other markets for years but was unavailable in the U.S. due to the FDA’s lengthy review process for new OTC sunscreen actives. Prior to 2020, new sunscreen ingredients had to go through a time-and-extent application (TEA) process under the OTC drug monograph system, a pathway that proved slow and cumbersome for novel ingredients. 

The passage of the CARES Act in 2020 reformed the OTC monograph process by granting the FDA authority to issue administrative orders rather than relying on the traditional rulemaking process. This streamlined pathway gave the agency a more efficient mechanism to evaluate and authorize new ingredients. Bemotrizinol is the first sunscreen active to complete this updated process, with the FDA issuing a proposed order on December 12, 2025, followed by a public comment period through January 26, 2026, and the final order on June 9, 2026. 

The FDA evaluated safety and efficacy data submitted by the ingredient’s sponsor, DSM Nutritional Products LLC, and determined that bemotrizinol meets the criteria for general recognition as safe and effective (GRASE) at concentrations up to 6 percent for adults and children 6 months of age and older. The final order specifies the permitted concentration levels and labelling requirements for products containing the ingredient.  

Why Bemotrizinol Matters for Sunscreen Formulations

The addition of bemotrizinol gives formulators meaningful new chemistry to work with. U.S. sunscreen manufacturers have historically had a narrower set of active ingredients than their international counterparts. Many UV filters available in Europe and Asia, including several offering superior photostability or broader spectral coverage, have remained off-limits for U.S. products.

Bemotrizinol’s broad-spectrum absorption profile makes it valuable for several reasons. Formulators can combine it with other permitted actives to achieve higher SPF ratings. It also supports more balanced UVA/UVB protection without requiring the high concentrations of existing ingredients that can affect product texture and consumer acceptance. The ingredient is also oil-soluble and photostable, so it does not degrade rapidly under sun exposure. This sets it apart from some currently approved organic filters.

Companies that already manufacture and sell bemotrizinol-containing products in other jurisdictions may find U.S. market entry more straightforward. They will still need to meet FDA-specific labelling, formulation, and manufacturing requirements for OTC drugs.

Broader Regulatory Context 

This approval signals movement on a broader question: will the FDA continue evaluating and authorizing other UV filters already approved internationally? The agency is reviewing several other ingredients. The speed and outcome of the bemotrizinol decision may influence how quickly those reviews progress.

Companies marketing sunscreen products in both the U.S. and Canada should confirm how their specific formulation is classified in each market. Permitted concentrations, labelling standards, and product classification can differ between the two regulatory frameworks, even where an ingredient is broadly permitted in both. Companies operating across both markets need to account for these differences in their compliance strategies.

What This Means for Your Business 

The FDA’s decision creates an immediate opportunity for sunscreen manufacturers and sun care brands. Companies can reformulate existing products or develop new ones that incorporate bemotrizinol. That said, adding a newly approved ingredient is rarely a simple drop-in change.

Reformulating an OTC sunscreen product triggers several compliance obligations. These include stability testing, labelling updates, Good Manufacturing Practice (GMP) documentation, and in some cases new submissions or notifications, depending on the specifics of the formulation change.

Next Steps for Multi-Market Sellers

Companies selling sunscreen products in multiple jurisdictions should review their product portfolios. This helps identify where bemotrizinol could fit and whether formulations used in markets like Europe or Canada could be adapted for U.S. sale. Regulatory teams should also monitor the FDA’s ongoing review of other pending UV filter applications, since additional approvals could further shift the competitive landscape.

Firms without deep in-house regulatory capacity may benefit from external advisory support to ensure that reformulated or new products meet all applicable requirements before reaching the market. Quality Smart Solutions provides regulatory consulting services to help companies align their product development and compliance programs with current FDA and Health Canada requirements.